China's new biosimilars guideline: more flexibility, but stricter in parts
This article was originally published in SRA
The China Food and Drug Administration has released the final version of its biosimilars guideline1.
You may also be interested in...
The road to China's health-care market, once seen to be paved with gold by many medtech companies, is presenting more obstacles than before as a result of increased local competition and challenging policies. Multinationals and start-ups attending the recent China Healthcare Investment Conference discussed ways in which the medtech industry could continue to capitalize on this market's potential.
China is pushing ahead with initiatives in the precision medicine area, where it sees targeted diagnosis and treatment as particularly valuable in areas such as oncology, diabetes and cardiovascular disorders.
Three months after publishing its draft guideline on biosimilars, China's Food and Drug Administration (CFDA) has just released the final official version, although it is still described as a pilot scheme. The new guideline may look similar to the draft on the surface, but a closer comparison reveals many differences.